GxPlex

Jurisdiction: International

41 of 86 tracked instruments.

This is a projection of the tracker, not a separate dataset. Its canonical URL is the tracker.

Status unknown 3 frozen 21 final 17

Ordered by the lifecycle the values themselves name.

Class (as stated) no self-stated class 16 consensus standard 20 authority guidance 5

The words a document uses about itself. One that uses none is filed under "no self-stated class" — a fact about the reading, not a kind of document.

Two facets compose at a time.

Showing 41 of 86 instruments. Clear all filters

Jurisdiction: International — 41 instrument(s) — no change has been detected yet, so rows are alphabetical; they order by change date as soon as one is
Instrument Authority Jurisdiction Status Last verified Last changed Source
Annex 15 revision concept paper European Medicines Agency and Pharmaceutical Inspection Co-operation Scheme International not yet verified awaiting link (opens in new tab)
ASTM E2363 ASTM International International final verified 2026-07-29 link (opens in new tab) · retrieved
ASTM E2500 ASTM International International final verified 2026-07-29 link (opens in new tab) · retrieved
ASTM E2537 ASTM International International final tool-read paywalled — progression tracked 2026-07-31 link (opens in new tab) · retrieved
DI revision concept paper European Medicines Agency and Pharmaceutical Inspection Co-operation Scheme International not yet verified frozen listing only link (opens in new tab)
FDA/EMA AI principles US Food and Drug Administration and European Medicines Agency International not yet verified awaiting link (opens in new tab)
GAMP 5 2nd Ed ISPE International not yet verified frozen paywalled — progression tracked link (opens in new tab)
GAMP AI Guide ISPE International not yet verified frozen paywalled — progression tracked link (opens in new tab)
ICH E6(R3) International Council for Harmonisation International final verified 2026-07-29 link (opens in new tab) · retrieved
ICH Q12 International Council for Harmonisation International final verified 2026-07-29 link (opens in new tab) · retrieved
ICH Q13 International Council for Harmonisation International final verified 2026-07-29 link (opens in new tab) · retrieved
ICH Q14 International Council for Harmonisation International final verified 2026-07-29 link (opens in new tab) · retrieved
ICH Q2(R2) International Council for Harmonisation International final verified 2026-07-30 link (opens in new tab) · retrieved
ICH Q9(R1) International Council for Harmonisation International final verified 2026-07-29 link (opens in new tab) · retrieved
IEC 62304 ISO/IEC International final tool-read paywalled — progression tracked 2026-07-31 link (opens in new tab) · retrieved
IEC 62443 IEC / ISA International not yet verified frozen paywalled — progression tracked link (opens in new tab)
IEEE 7000 Institute of Electrical and Electronics Engineers International final verified 2026-07-30 link (opens in new tab) · retrieved
IMDRF AI/ML WG International Medical Device Regulators Forum International not yet verified frozen blocks automated requests link (opens in new tab)
IMDRF SaMD International Medical Device Regulators Forum International not yet verified frozen blocks automated requests link (opens in new tab)
ISO 13485 ISO/IEC International final tool-read paywalled — progression tracked 2026-07-31 link (opens in new tab) · retrieved
ISO 14971 ISO/IEC International final tool-read paywalled — progression tracked 2026-07-31 link (opens in new tab) · retrieved
ISO/IEC 22989 ISO/IEC International final verified 2026-07-29 link (opens in new tab) · retrieved
ISO/IEC 23894 ISO/IEC International final verified 2026-07-29 link (opens in new tab) · retrieved
ISO/IEC 24028 ISO/IEC International final verified 2026-07-29 link (opens in new tab) · retrieved
ISO/IEC 27001 ISO/IEC International final verified paywalled — progression tracked 2026-08-01 link (opens in new tab) · retrieved
ISO/IEC 27002 ISO/IEC International final verified paywalled — progression tracked 2026-08-01 link (opens in new tab) · retrieved
ISO/IEC 27017 ISO/IEC International withdrawn verified paywalled — progression tracked 2026-08-01 link (opens in new tab) · retrieved
ISO/IEC 27018 ISO/IEC International withdrawn verified paywalled — progression tracked 2026-08-01 link (opens in new tab) · retrieved
ISO/IEC 38507 ISO/IEC International final verified 2026-07-29 link (opens in new tab) · retrieved
ISO/IEC 42001 ISO/IEC International final verified 2026-07-29 link (opens in new tab) · retrieved
ISO/IEC 42005 ISO/IEC International final verified 2026-07-29 link (opens in new tab) · retrieved
ISO/IEC 5259 ISO/IEC International final verified 2026-07-29 link (opens in new tab) · retrieved
ISO/IEC SC 42 ISO/IEC International not yet verified frozen not a document 2026-07-31 link (opens in new tab) · retrieved
ISPE Pharma 4.0 International Society for Pharmaceutical Engineering International not yet verified frozen not a document link (opens in new tab)
NIST AI RMF US National Institute of Standards and Technology International not yet verified checked — no status stated 2026-08-01 link (opens in new tab) · retrieved
PIC/S Annex 11 Pharmaceutical Inspection Co-operation Scheme International not yet verified frozen listing only link (opens in new tab)
PIC/S GMP Guide Pharmaceutical Inspection Co-operation Scheme International not yet verified frozen paywalled — progression tracked link (opens in new tab)
PIC/S PI 041 Pharmaceutical Inspection Co-operation Scheme International final verified paywalled — progression tracked 2026-08-01 link (opens in new tab) · retrieved
WHO AI health World Health Organization International final tool-read 2026-07-30 link (opens in new tab) · retrieved
WHO computerised systems World Health Organization International not yet verified frozen listing only link (opens in new tab)
WHO data management World Health Organization International not yet verified frozen listing only link (opens in new tab)

Last updated: